DPW · Class II · 21 CFR 870.2100

FDA Product Code DPW: Flowmeter, Blood, Cardiovascular

Leading manufacturers include Koven Technology, Inc., Transonic Systems, Inc. and Koven and Assoc., Inc..

139
Total
139
Cleared
165d
Avg days
1976
Since
139 devices
49–72 of 139
Cleared May 14, 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505
Terumo Cardiovascular Systems Corp.
Cardiovascular · 84d
Cleared Apr 23, 2003
VTI 20 MHZ GATED DOPPLER
K031091
Vascular Technology Incorporated
Cardiovascular · 16d
Cleared Nov 13, 2002
QUANTIX/ND DEVICE
K023431
Cardiosonix, Ltd.
Cardiovascular · 29d
Cleared May 08, 2002
QFLOW 500 PERFUSION MONITORING SYSTEM
K013376
Hemedex Incorporated
Cardiovascular · 209d
Cleared Feb 13, 2002
FLOWGUARD DEVICE
K013803
Biosonix , Ltd.
Cardiovascular · 90d
Cleared Feb 12, 2002
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
K010452
Koven Technology, Inc.
Cardiovascular · 362d
Cleared Nov 06, 2001
PF 5050 PRESSURE UNIT, MODEL PF 5050
K011899
Perimed AB
Cardiovascular · 141d
Cleared May 02, 2001
VASCULAR ASSIST
K002186
Huntleigh Healthcare, Inc.
Cardiovascular · 286d
Cleared Nov 17, 2000
TISSUE SPECTROSCOPE
K992529
Vital Medical , Ltd.
Cardiovascular · 478d
Cleared Aug 19, 1999
JOSTRA HL-20 TWIN PUMP
K984338
Jostra Bentley
Cardiovascular · 259d
Cleared Aug 03, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4100
K992387
Rossmax International , Ltd.
Cardiovascular · 15d
Cleared Aug 03, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4200
K992388
Rossmax International , Ltd.
Cardiovascular · 15d
Cleared May 20, 1999
WRIST BLOOD PRESSURE METER MODEL SE-330
K973078
Sein Electronics Co., Ltd.
Cardiovascular · 640d
Cleared Nov 24, 1998
TUBING BLOOD FLOW METER MODEL NUMBER HD-800
K982986
Koven Technology, Inc.
Radiology · 90d
Cleared Oct 14, 1998
VGF-7 VASCULAR GRAFT FLOWMETER
K973198
Medicard , Ltd.
Cardiovascular · 414d
Cleared May 28, 1998
PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
K974285
Perimed, Inc.
Cardiovascular · 195d
Cleared Apr 30, 1998
MICROLIFE MANUAL BLOOD PRESSURE MONITOR (MANUAL INFLATE) MODEL BP-2BIO
K970139
Micro Weiss Electronics
Cardiovascular · 470d
Cleared Apr 30, 1998
MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR
K970211
Micro Weiss Electronics
Cardiovascular · 464d
Cleared Mar 13, 1998
MS-700
K972213
Alan S. Lee
Cardiovascular · 274d
Cleared Feb 24, 1998
DYNEMO 3000
K972798
Sometec, Inc.
Radiology · 211d
Cleared Mar 29, 1996
BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY
K954397
Koven Technology, Inc.
Radiology · 191d
Cleared Nov 07, 1995
EDM
K951369
Deltex Medical
Cardiovascular · 225d
Cleared Jun 29, 1995
MODEL PV2000 VASCULAR MICROLABORATORY
K951486
Vasamedics, LLC
Cardiovascular · 91d
Cleared Dec 23, 1994
SMARTDOP 30 BI-DIRECTIONAL BLOOD FLOW DETECTOR
K942613
Koven Technology, Inc.
Radiology · 204d